The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn. Bhd. with the FDA for Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (black).
| Device ID | K190080 |
| 510k Number | K190080 |
| Device Name: | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Black) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang Matang, MY 34750 |
| Contact | Chan Yew Men |
| Correspondent | Chan Yew Men Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang Matang, MY 34750 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-16 |
| Decision Date | 2019-06-27 |